Panels › Hematology › Product code LIM · Class 2
Test, Screening, For D Positive Fetal Rbc'S
Regulation 864.7455
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LIM
| Company | 510(k)s | Recalls |
|---|---|---|
| Biopool Intl., Inc. | 1 | 0 |
| Gamma Biologicals, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 8, 1998 | K980314 | FETAL D TECTION KIT Biopool Intl., Inc. | LIM |
| May 12, 1982 | K820647 | GAMMA FETAL BLEED SCREENING TEST Gamma Biologicals, Inc. | LIM |
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